Eval EarlySense Bet Lowenstein Sleeplab

Evaluation of EarlySense - a Contact-less Heart and Respiration Rate Monitor in Hospitalized Patients

The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient turns will also be collected and compared to data collected by EarlySense contactless monitor. Different patient population will be monitored including obese, morbidly obese, patients with or without obstructive/central apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored

Study Overview

• Status: Withdrawn
• Conditions: Sleep Apnea, Obstructive; Obese; Sleep Disorders; Poor Quality Sleep; Central Apnea

Detailed Description

EarlySense sensors will be placed under the mattress of subjects who have been included in the study. The sensors will not be in any contact with the patient. Two sensors will be utilized and placed under the subject's chest and pelvis area. Accuracy of the sensors will be compared to each other and to the reference device.

• Study Type: Observational

Contacts and Locations

Study Locations

• Israel
  • Raa'nana, Israel
    • Beit Lowenstien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Different patient population will be monitored including obese, morbidly obese, patients with or without apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored

Description

Inclusion Criteria:

1. Age 18 years or above
2. Is willing to sign the consent form

Exclusion Criteria:

1. Age < 18 years
2. Is not willing to sign the consent form

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
sleeplab; Sleep Lab examined, usualy with some obesity or sleeping disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab	the measurements from the EarlySense System will be compared with the "Gold standard" equipment that is being used in the sleep Lab	up to 12 hours

Collaborators and Investigators

• Sponsor: EarlySense Ltd.
• Investigators: Principal Investigator: Tatiana Vander, MD, Beit Lowenstein Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): February 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 24, 2013
• First Submitted That Met QC Criteria: November 6, 2013
• First Posted (Estimate): November 7, 2013

Study Record Updates

• Last Update Posted (Estimate): July 19, 2016
• Last Update Submitted That Met QC Criteria: July 17, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Apnea; Sleep Apnea, Central
• Other Study ID Numbers: ES-CLC-2013_Prot_1